NPI Engineer II – New Product Introduction (Visa Required)

About the role

The NPI Engineer II supports design, development, documentation, and validation of new or transferred medical device products. Working within a cross‑functional team, the engineer leads key engineering processes, ensures compliance with quality standards, and collaborates with customers, suppliers, and internal stakeholders.

Key responsibilities

• Lead and participate in project meetings, develop and maintain project plans, and track milestones, budgets, and quality requirements.
• Support product transfers and development initiatives, including feasibility builds, documentation, testing, and process validation.
• Conduct PFMEA, process development, equipment evaluation, and operator training.
• Assist in design verification, validation, and creation of product specifications, fixturing, and packaging.
• Provide technical support to troubleshoot production processes and recommend test methods.

Required profile

• Bachelor’s degree in Mechanical, Manufacturing, Biomedical, or related engineering discipline.
• 3–5 years of engineering experience, including NPI or product transfer work in the medical device industry.
• Experience with design validation, prototyping, process development, and technical documentation.
• Ability to read and interpret technical drawings, specifications, and blueprints under mentorship.
• Visa and passport required; high level of English proficiency.

Required skills

• Proficiency with MS Office suite (Excel, Word, PowerPoint, Microsoft Project).
• Experience using project tracking tools.
• Familiarity with CAD and design tools (advantageous).
• Knowledge of PFMEA and process validation methodologies.